Systems and methods of performing surgery using Laplace&#39;s law tension retraction during surgery

ABSTRACT

Disclosed are embodiments of an apparatus and system for performing a sleeve gastrectomy. The apparatus can include a bougie for insertion into an interior of a stomach, the bougie having a proximal bougie end and a distal bougie end, an inflation lumen having a proximal lumen end and a distal lumen end, the inflation lumen extending from the proximal bougie end through the distal bougie end, a fluid delivery system coupled with the proximal lumen end, the fluid delivery system being operably configured to deliver positive pressure in a predetermined positive pressure range into the stomach, and a monitor coupled with the proximal lumen end operably configured for the monitoring of pressure or volume within the stomach. The bougie can be operably configured to define a resection line for the sleeve gastrectomy when the predetermined positive pressure range is achieved within the stomach

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the priority benefit of U.S. Provisional PatentApplication No. 62/930,254, filed Nov. 4, 2019, which is herebyincorporated herein by reference in its entirety.

TECHNICAL FIELD

The examples herein may be directed to a sleeve gastrectomy, and moreparticularly to a bougie or medical tube inserted into the stomach andused in conjunction with a sleeve gastrectomy stapler or clamp. Theexample devices herein may provide proper tension of the stomach tissueduring clamping of the stapler or clamp during the creation of avertical sleeve gastrectomy.

BACKGROUND

Obesity is a disease that affects a significant portion of the world'spopulation and leads to multiple chronic medical conditions andpremature death from cardiovascular events and cancer. In particular,the United States has a current, and worsening obesity epidemic. TheU.S. Centers for Disease Control and Prevention (CDC) reports that over33% of the U.S. population is obese, with a Body Mass Index (BMI) ofover 30, and another 35-40% of the US population is overweight, with aBMI of 25-30. The CDC reports that the percent of the US populationbeing either overweight or obese by 2018 will be 75%. The CDC alsoreports that obesity directly costs the U.S. economy $147 billioncurrently, and projects that the costs will approach $315 billion by2020.

Further, obesity has environmental, genetic, and behavioral origins butis intractable to most medical and behavioral interventions. To helpreduce obesity and/or facilitate weight loss, bariatric surgery may bean option for some patients that may be overweight. Typically, bariatricsurgery may be an effective long-term treatment option for patients witha BMI greater than 35. Despite the 20 million patients who are eligiblefor weight loss surgery in the U.S., the number of procedures per yearhas plateaued at about 200 thousand, eliminating any public healtheffect of surgery.

In recent years, a popular form of bariatric surgery may include alaparoscopic vertical sleeve gastrectomy (e.g., which may removeapproximately 80% of the stomach). Laparoscopic vertical sleevegastrectomy may be a procedure that may be safer and more effective forpatients eligible for weight loss surgery. In fact, it has been acceptedas the surgery that should be offered to most morbidly obese patientsover, for example, laparoscopic adjustable gastric banding andlaparoscopic Roux-en-Y gastric bypass. As such, the surgery has beenadopted by bariatric surgeons and is now the most commonly performedweight loss surgery.

Vertical sleeve gastrectomy is typically performed using standardlaparoscopic equipment. The greater curvature of the stomach ismobilized using vessel-sealing devices, sealing the gastric branches ofthe gastroepiploic vessels and the short gastric vessels. The posterioradhesions of the stomach are also divided so the stomach is fullymobilized while the blood supply to the lesser curvature remains intact.

Following mobilization of the stomach a calibration tube is typicallyintroduced into the stomach through the mouth. Resection is accomplishedby applying a series of staples from a laparoscopic linear surgicalstapler, for example, along the calibration tube in a staple line. Thestaple line may be important in sleeve gastrectomy as the amount ofweight lost and complications or consequences may be a direct result ofthe quality of the resultant sleeve gastrectomy pouch formed from thestaple line (e.g., the portion of the stomach not rescinded by thestaple line). The complications or consequences may includegastroesophageal reflux disorder (GERD), weight loss failure or weightregain, food intolerance, staple line bleed, leak, and/or the like.

The stomach resection line is long (e.g., up to 22 cm). While thestomach is being stapled, sections of the stomach are retracted. Eachsection may be, for example, 3 cm in length and requires incorporationof equal amounts of the anterior and posterior sides of the stomach.Stomach tissue can be modelled as a series of ropes or elastic fibers.These must be pulled in the correct traction force vector relative tothe clamp or stapler with 4 dimensions or axes of direction (i.e.,up/down or anterior/posterior; left/right; caudad/cephalad; androtation) and 1 dimension of magnitude. Maintaining proper tensionduring each clamp or staple is important to produce a sleeve gastrectomypouch (e.g., from the staple line) without negatively affecting orinterfering with the natural elasticity of the tissue.

To help produce a repeatable sleeve gastrectomy pouch, a sleevegastrectomy shaping tube may be used. Unfortunately, the surgeon muststill manually manipulate the stomach to apply tension while planningthe resection line using existing methods.

SUMMARY

Disclosed are embodiments of an apparatus for performing a sleevegastrectomy, where the apparatus can include a bougie for insertion intoan interior of a stomach, the bougie having a proximal bougie end and adistal bougie end, an inflation lumen having a proximal lumen end and adistal lumen end, the inflation lumen extending from the proximal bougieend through the distal bougie end, a fluid delivery system coupled withthe proximal lumen end, the fluid delivery system being operablyconfigured to deliver positive pressure in a predetermined positivepressure range into the stomach, and a monitor coupled with the proximallumen end operably configured for the monitoring of pressure or volumewithin the stomach. The bougie can be operably configured to define aresection line for a sleeve gastrectomy when the predetermined positivepressure range is achieved within the stomach.

The bougie can include at least one balloon portion positioned at thedistal bougie end. The inflation lumen can be used for both inflationand suction. The fluid delivery system can be a hand pump or a footpump. The monitor can be a visual indicator or an audible indicator. Themonitor can include a control system for metering a fluid deliveredthrough the inflation lumen. The bougie can include at least one sensorcoupled with the distal bougie end for monitoring a pressure or volumewithin the stomach. The distal bougie end can include a shaping portionthat can be a balloon or an articulating tip. The distal bougie end caninclude an overtube. The inflation lumen can be a multi-lumen catheter.The predetermined positive pressure range can be from 15 mmHG to 20mmHG.

Disclosed are embodiments of an apparatus for performing a sleevegastrectomy, where the apparatus can include a bougie for insertion intoan interior of a stomach, the bougie having a proximal bougie end and adistal bougie end, an inflation lumen having a proximal lumen end and adistal lumen end, the inflation lumen extending from the proximal bougieend through the distal bougie end, a fluid delivery system coupled withthe proximal lumen end, the fluid delivery system being operablyconfigured to deliver a predetermined range of positive pressure intothe stomach, and a control system coupled with the proximal lumen endfor the metering and monitoring of pressure or volume within thestomach. The bougie can be operably configured to cooperate with astapler or clamp to define a resection line for a sleeve gastrectomywhen the predetermined positive pressure range is achieved within thestomach.

Embodiments of a system for performing a sleeve gastrectomy can includea first medical device, the first medical device having a bougie forinsertion into an interior of a stomach, the bougie having a proximalbougie end and a distal bougie end, an inflation lumen having a proximallumen end and a distal lumen end, the inflation lumen extending from theproximal bougie end through the distal bougie end, a pump coupled withthe proximal lumen end, the pump being operably configured to deliver apredetermined positive pressure range into the stomach, a monitorcoupled with the proximal lumen end for the monitoring of pressure orvolume of the stomach, and a shaping portion, the shaping portion beingpositioned at the distal bougie end, wherein the shaping portion isoperably configured to position a portion of the stomach. The system caninclude a second medical device, the second medical device being astapler or clamp positioned externally on the stomach laterally adjacentto the first medical device. In the system, the first medical device andthe second medical device can be operably configured to define aresection line for a sleeve gastrectomy when the predetermined positivepressure range is achieved within the stomach and the second medicaldevice can be operably configured to clamp the stomach along theresection line.

Example methods for performing a sleeve gastrectomy can include thesteps of providing a first medical device including a tube for insertioninto an interior of a stomach, the tube having a proximal end and adistal end, the distal end comprising a shaping portion; providing aninflation lumen for the introduction of positive pressure into thestomach; providing a second medical device, the second medical devicebeing a stapler or clamp positioned externally on the stomach laterallyadjacent to the first medical device; introducing positive pressure intothe stomach via the inflation lumen; defining a resection line for asleeve gastrectomy, wherein the resection line is defined at leastpartially by the position of the second medical device relative to thefirst medical device when a predetermined positive pressure range isprovided via the inflation lumen; and clamping the stomach using thesecond medical device along the resection line.

Methods can include a bougie including the inflation lumen. The firstmedical device can comprise a bougie having a first balloon portion, thefirst balloon portion having a first balloon inflation lumen. The firstballoon portion can be a non-compliant balloon having a predeterminedshape in an inflated configuration. Methods can include an indicatorassociated with the predetermined positive pressure range of the stomachbeing achieved. The indicator can be a visual or audible indicatorsignaling that a positive pressure within the stomach is below thepredetermined positive pressure range, above the predetermined positivepressure range, or within the predetermined positive pressure range. Thepredetermined positive pressure range can be from 1 mmHG to 25 mmHG. Thepredetermined positive pressure range can be from 15 mmHg to 20 mmHg.The method can include providing a release for when a pressure withinthe stomach is greater than the predetermined positive pressure range.The first medical device can include a suction portion and an inflationportion, where the suction portion is operably configured to urge afirst portion of the stomach proximate the suction portion and theinflation portion is operably configured to inflate the stomach to thepredetermined positive pressure range. The suction portion can bepositioned proximate the GE junction of the stomach. The suction portioncan be positioned proximate the antrum of the stomach. The suctionportion of the first medical device can extend from a portion proximatethe GE junction of the stomach to a portion proximate the antrum of thestomach. The inflation lumen can be selectively configured to providesuction. The distal end of the first medical device can include anarticulating member, the articulating member being operably configuredto position the antrum relative to the second medical device.

Example methods where defining a resection line comprises applying afirst amount of compression to the stomach with the second medicaldevice when the positive pressure is introduced into the stomach, andapplying a second amount of compression to the stomach when pressurewithin the stomach has reached the predetermined positive pressurerange, wherein the second amount of compression is greater than thefirst amount of compression and the second amount of compression isoperably configured to immovably retain the stomach. Example methodswhere the step of clamping includes providing a first clamping forcewith the second medical device prior to the resection line beingdefined, and a second clamping force with the second medical deviceafter the resection line is defined to immovably secure the stomachtherein. Example methods where the step of clamping includes firstclamping a lower portion of the stomach, defining the resection line,and clamping the full length of the stomach using the second medicaldevice. Example methods where the step of clamping the stomach with thesecond medical device comprises stapling the stomach and resecting aportion of the stomach.

In example methods, the first medical device can comprise a plurality ofballoon portions. The distal end of the first medical device can beoperably configured to articulate. The first medical device can includeat least one sensor to measure the pressure or volume within thestomach. The first medical device or the second medical device include asensor to measure tension, pressure, or volume of the stomach.

Example methods in accordance with embodiments described herein caninclude the steps of providing a first medical device including a tubefor insertion into an interior of a stomach, the tube having a proximalend, a distal end, and at least one balloon portion, the distal endcomprising a shaping portion; providing an inflation lumen for theintroduction of positive pressure into the stomach, wherein theinflation lumen is coupled with a pump, a pressure gauge, and a pressurerelease valve; providing a second medical device, the second medicaldevice being a stapler or clamp positioned externally on the stomachlaterally adjacent to the first medical device; introducing positivepressure into the stomach via the inflation lumen until a predeterminedrange of pressure is achieved; defining a resection line for a sleevegastrectomy, wherein the resection line is defined at least partially bythe position of the second medical device relative to the first medicaldevice when the predetermined positive pressure range is achieved;clamping the stomach using the second medical device along the resectionline; stapling the stomach using the second medical device along theresection line; and resecting a portion of the stomach using the secondmedical device to form a sleeve gastrectomy.

Example methods can include a bougie, the bougie including the inflationlumen. The first medical device can comprise a bougie having at leastone balloon portion, the at least one balloon portion having at leastone balloon inflation lumen. Example methods can include an indicatorfor determining when the predetermined positive pressure range of thestomach has being achieved. The indicator can be a visual or audibleindicator signaling that a positive pressure within the stomach is belowthe predetermined threshold range, above the predetermined thresholdrange, or within the predetermined threshold range. The predeterminedpositive pressure range can be from 1 mmHG to 25 mmHG. The predeterminedpositive pressure range can be from 15 mmHg to 20 mmHg.

In example methods, the first medical device can include a suctionportion and an inflation portion, where the suction portion is operablyconfigured to urge a first portion of the stomach proximate the suctionportion and the inflation portion is operably configured to inflate thestomach to the predetermined positive pressure range. The suctionportion can be positioned proximate the GE junction of the stomach,proximate the antrum of the stomach, or can extend from a portionproximate the GE junction of the stomach to a portion proximate theantrum of the stomach. The inflation lumen can be selectively configuredto provide suction. The distal end of the first medical device caninclude an articulating member, the articulating member being operablyconfigured to position the antrum relative to the second medical device.The first medical device can include at least one sensor to measurepressure or volume within the stomach.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure will be more readily understood from a detaileddescription of some example embodiments taken in conjunction with thefollowing figures:

FIG. 1 depicts a perspective view of a system according to anembodiment, the system including a first medical device and a secondmedical device positioned relative to a stomach.

FIG. 2A depicts a perspective view of the first medical device of thesystem of FIG. 1 .

FIG. 2B depicts an elevation view of the first medical device of thesystem of FIG. 1 .

FIG. 2C depicts a cross-sectional view of the first medical device ofFIG. 2A taken along section 2C-2C.

FIG. 3 is a flow chart depicting a fluid delivery system according to anembodiment.

FIG. 4A is a flow chart depicting a fluid delivery system according toanother embodiment.

FIG. 4B is a flow chart depicting a fluid delivery system according toanother embodiment.

FIG. 4C depicts a perspective view of a hand pump according to anembodiment.

FIG. 5A depicts a perspective view of the system of FIG. 1 where thefirst medical device is positioned in the stomach lumen and the secondmedical device is positioned outside the stomach adjacent to the firstmedical device in an example method of creating a resection path duringa sleeve gastrectomy.

FIG. 5B depicts a perspective view of the system of FIG. 1 where theshaping portion of the first medical device is inflated and the stomachlumen is being pressurized.

FIG. 5C depicts a perspective view of the system of FIG. 1 where thepressure in the stomach has increased to urge the second medical deviceagainst the first medical device.

FIG. 5D depicts a perspective view of the system of FIG. 1 where thesecond medical device has been clamped.

FIG. 5E depicts a perspective view of the system of FIG. 1 where theshaping portion of the first medical device and the stomach lumen havebeen deflated.

FIG. 6A depicts an elevation view of a distal portion of a first medicaldevice capable of applying suction according to an embodiment.

FIG. 6B depicts an elevation view of a distal portion of a first medicaldevice capable of applying suction according to another embodiment.

FIG. 6C depicts an elevation view of a distal portion of a first medicaldevice capable of applying suction according to another embodiment.

FIG. 7 depicts a perspective view of a first medical device including anovertube in accordance with an embodiment.

FIG. 8A depicts a cross-sectional view of a first medical deviceincluding a gastroscope in according to an embodiment.

FIG. 8B depicts a cross-sectional view of a first medical deviceincluding a gastroscope in accordance with another embodiment.

FIG. 9 depicts a perspective view of a system according to anembodiment, the system including a first medical device and a secondmedical device positioned relative to a stomach, and a connectorattached to two sections of the stomach tissue.

FIG. 10 depicts a perspective view of a first medical device includingan articulating tip in accordance with an embodiment.

FIG. 11A depicts a perspective view of a first medical device includinga tissue anchor in accordance with an embodiment.

FIG. 11B depicts a perspective view of the first medical device of FIG.11B and a stylet used to straighten the first medical device aftertissue has been anchored to the tissue anchor.

FIG. 12A depicts an elevation view of a first medical device including aperforated sheath in accordance with an embodiment.

FIG. 12B depicts an elevation view of the first medical device of FIG.12A with the shaping portion in an expanded state.

FIG. 12C depicts a cross-sectional view of the first medical device ofFIG. 12A with the shaping portion in an expanded state.

FIG. 13 depicts a perspective view of a first medical device includingan inflatable balloon extending through the pyloric sphincter inaccordance with an embodiment.

FIG. 14A depicts a perspective view of the system of FIG. 1 including aninflatable balloon inserted into the stomach lumen on the remnant side.

FIG. 14B depicts a perspective view of the system of FIG. 14A after theballoon has been inflated.

FIG. 15 depicts a perspective view of a first medical device including asegmented shaping portion in accordance with an embodiment.

FIG. 16A depicts a cross-sectional view of a first medical deviceincluding suction zones in accordance with an embodiment, where thesecond medical device is in a first position.

FIG. 16B depicts a cross-sectional view of the first medical device ofFIG. 16A, where the second medical device is in a second position.

FIG. 16C depicts a cross-sectional view of the first medical device ofFIG. 16A, where the second medical device is in a third position.

FIG. 17A depicts a perspective view of a tube portion of a first medicaldevice including suction zones in accordance with an embodiment.

FIG. 17B depicts a perspective view of the tube portion of FIG. 17A withthe cap removed.

FIG. 18A depicts a perspective view of a first medical device includingsuction zones in accordance with an embodiment.

FIG. 18B depicts a perspective view of a shaping portion of the firstmedical device of FIG. 18A.

FIG. 18C depicts a perspective view of the shaping portion and the tubeportion of the first medical device of FIG. 18A.

FIG. 18D depicts a perspective view of a manifold cap of the firstmedical device of FIG. 18A.

FIG. 19A depicts a cross-sectional view of a first medical deviceincluding suction zones in accordance with another embodiment.

FIG. 19B depicts a cross-sectional view of a first medical device ofFIG. 19A with the shaping portion inflated.

DETAILED DESCRIPTION

Various non-limiting embodiments of the present disclosure will now bedescribed to provide an overall understanding of the principles of thestructure, function, and use of the apparatuses, systems, methods, andprocesses disclosed herein. One or more examples of these non-limitingembodiments are illustrated in the accompanying drawings. Those ofordinary skill in the art will understand that systems and methodsspecifically described herein and illustrated in the accompanyingdrawings are non-limiting embodiments. The features illustrated ordescribed in connection with one non-limiting embodiment may be combinedwith the features of other non-limiting embodiments. Such modificationsand variations are intended to be included within the scope of thepresent disclosure.

Reference throughout the specification to “various embodiments,” “someembodiments,” “one embodiment,” “some example embodiments,” “one exampleembodiment,” or “an embodiment” means that a particular feature,structure, or characteristic described in connection with any embodimentis included in at least one embodiment. Thus, appearances of the phrases“in various embodiments,” “in some embodiments,” “in one embodiment,”“some example embodiments,” “one example embodiment,” or “in anembodiment” in places throughout the specification are not necessarilyall referring to the same embodiment. Furthermore, the particularfeatures, structures or characteristics may be combined in any suitablemanner in one or more embodiments.

As described herein, systems and/or methods may be provided forperforming a sleeve gastrectomy without disturbing the natural tensionlines of the stomach tissue. Additionally, the systems and/or methodsdescribed herein may allow for proper sizing of the resulting sleevegastrectomy pouch. Referring to FIG. 1 , some embodiments include asystem 10 including a first medical device 100, such as a bougie, and asecond medical device 300, such as a clamp or stapler. According to anexample herein, the first and second medical devices 100, 300 may beused to perform a vertical sleeve gastrectomy. The sleeve gastrectomy(e.g., resection of part of the stomach) may be performed along a path,such as a resection line, to produce a resultant sleeve gastrectomypouch (“sleeve”) of the stomach 12. For example, a first medical device100 may be positioned in an interior of the stomach 12. The firstmedical device 100 may include or have a first diameter along a firstportion thereof (e.g., a bougie or tube, such as an orogastric tube) anda second diameter that may be larger than the first diameter along asecond portion thereof (e.g., a shaping portion, an inflated portion, ora radially-outward projecting portion). The first medical device 100 maybe positioned, for example, by inserting the first medical device into amouth of a patient to access the interior of the stomach 12 andpositioning the second portion at a landmark of the stomach 12, asdiscussed further below. The second medical device 300 may be positionedon an exterior of the stomach 12 relative to or based on an interactionwith the first medical device 100 (e.g., adjacent to, near, in proximityto, and/or interaction with the second portion of the first medicaldevice) such that the second medical device 300 may be configured todemonstrate or create a path such as a resection line or staple line)along the stomach 12 at which the sleeve gastrectomy may be performed.Positive pressure may be introduced to the lumen of the stomach 12,which is used to generate tension on the stomach wall according to theLaw of Laplace (T=P*R where T=tension, P=pressure, R=radius). Thetension may be uniform in the anterior/posterior plane (e.g., across atransverse cross-section of the stomach), although the tension wouldvary along the length of the stomach as the radius varies. The Law ofLaplace governs how a balloon inflates. The second medical device 300may be clamped partially or wholly while the stomach 12 is inflated.

Although some examples herein describe the second medical device 300 asa stapler, the disclosure is not so limited. For example, the secondmedical device 300 may be a clamp, such as a full length 23 cm clampconfigured to extend the full length of the stomach. The second medicaldevice 300 may include a first jaw 302 or first clamp member and asecond jaw 304 or second clamp member. The anatomical structure has afirst side and a second side. In an embodiment, the first jaw 302 mayhave a first end, a second end and a cartridge housing a plurality ofstaples, the cartridge having a cartridge face that may be positionableon the first side of the stomach, and the second jaw 304 may have afirst end, a second end, and an anvil having an anvil face that may bepositionable on the second side of the stomach. The second medicaldevice may include an end effector (e.g., including the jaws 302, 304)having a distal end 306 and a proximal end 308. Examples of suitablesecond medical devices are disclosed in U.S. Pat. Nos. 9,936,953,10,278,707, and 10,548,597, each of which is hereby incorporated hereinby reference in its entirety.

The first medical device 100 may be a shaping bougie, catheter, or tube,such as an orogastric tube. With reference to FIGS. 2A-2C, the firstmedical device 100 includes a tube portion 102 and a shaping portion104. The tube portion 102 may be generally cylindrical in shape and maybe made of, for example, rubber, silicone, polyurethane, a plasticpolymer, and/or any other suitable material. In an embodiment, thediameter of the tube portion 102 is constant. In another embodiment, thediameter of the tube portion 102 varies. The tube portion 102 may behollow, solid, define multiple internal lumen and/or the like in one ormore examples. The tube portion 102 may comprise a body 105 including aproximal end 106 that may be closer to a surgeon or other user to adistal end 108 that may be farther away from the surgeon. A section ofthe tube portion 102, ending at the distal end 108, or the distal bougieend, may be long enough to allow for easy insertion into the mouth,esophagus, and stomach, and/or may enable or allow the distal end 108 tobe navigated down towards the pylorus 14 of the stomach. The firstmedical device 100 may include an intragastric section 110 that, when inuse, is positioned in the stomach 12 adjacent the lesser curvature 16.The intragastric section 110 may include a proximal end 112 (i.e.,distal of the proximal end 106 of the tube portion 102). The location ofthe proximal end 112 may not be fixed along the length of the tubeportion 102. The distal end 108 of the tube portion 102 may also be thedistal end of the intragastric section 110. In some embodiments, thefirst medical device 100 may include lights or other visualizationfeatures to improve the use of the first medical device 100 as a guide(e.g., to aid with visualization through the stomach wall). The size ofthe tube portion may be, in various examples, in a range of 16 French(Fr) to 40 Fr, 16 Fr to 20 Fr, or 32 Fr to 40 Fr. Examples of a suitabletube portion 102 is a 18 Fr bougie, a 34 Fr bougie, or a 38 Fr bougie.

Still referring to FIGS. 2A-2C, in an embodiment, the shaping portion104 may comprise, for example, one or more inflatable balloons 114 orcollapsible portions. In various embodiments, the shaping portion 104may be adjustable between a first state having a first average diameterand a second state having a second average diameter. Where embodimentsdiscussed herein refer to a balloon that may have an inflated ordeflated state, the balloon may be interchangeable with a collapsibleportion that may have an expanded or retracted state. The balloon 114may be relaxed or deflated prior to use and insertion of the firstmedical device 100 in the stomach. In such an example (e.g., prior toinsertion and use), the tube portion 102 and the balloon 114 in therelaxed or deflated state may have a substantially constant diameter.The balloon 114 may be inflated to an inflated state after insertion ofthe first medical device 100 into the stomach to the appropriateposition. For example, a proximal end 116 of the shaping portion 104 maybe positioned adjacent to the GE junction 18 or the incisura angularis(IA) 20. The distal end 118 of the shaping portion 104 may be, forexample, positioned adjacent to the antrum 22. According to an example,the balloon 114 in the inflated state may have the second averagediameter. In some embodiments, when the shaping portion 104 is inflatedor expanded, the diameter of the shaping portion 104 may vary along thelength. For example, the inflated diameter at the distal end 118 of theshaping portion 104 may be greater than the diameter at the proximal end116. The size of the inflated or expanded shaping portion 104 may, in anembodiment, be determined based on the desired size of the resultingsleeve. An example of a suitable shaping portion 104 is a balloon with amaximum diameter of 2.5 cm. In another example, the maximum diameter ofthe shaping portion 104 may be about 3.2 cm. In an embodiment, the areaof the shaping portion 104 configured to have the maximum diameter maybe located adjacent the distal end 108 of the tube portion 102. Forexample, the area of the shaping portion 104 configured to have themaximum diameter may be located about 20 mm or less from the distal end108 of the tube portion 102. The minimum diameter of the shaping portionmay be, in an embodiment, about the diameter of the tube portion 102(e.g., slightly larger than the tube portion 102 diameter to allow theshaping portion 104 to extend around the tube portion 102). In anexample embodiment, the tube portion 102 is a 34 Fr catheter, and theshaping portion 104 includes a tapered balloon 114 having a minimumdiameter at the proximal end 116 of slightly greater than the diameterof the 34 Fr catheter, which increases along a length of 21 cm to thedistal end 118 where the maximum diameter is 3.2 cm. The length of theshaping portion 104 may vary. In an embodiment, the length of theshaping portion 104 may be in a range of about 4 cm to about 21 cm, 15cm to 20 cm, or about 21 cm.

The shaping portion 104, in combination with positive pressure in thestomach lumen, may enable the stomach tissue to have a proper anduniform tension applied to the stomach wall when the second medicaldevice 300 is clamped to the stomach. The tension may be uniform orsymmetric around a diameter (e.g., a transverse cross-section) of theresultant sleeve. For example, the first medical device 100 may beplaced with the balloon 114 adjacent the incisura angularis 20 in thedeflated state. The second medical device 300 may then be placed inapposition but not fully clamped, the balloon 114, which may becompliant or non-compliant, may be inflated to the inflated state. Thestomach lumen is also inflated, as described further below, whichcreates uniform tension in the stomach tissue of the intended sleeveprior to clamping. Once the desired tension is reached, at a pressure of20 mmHG for example, the second medical device 300 is clamped. Afterclamping, the balloon 114 may be deflated such that the first medicaldevice 100 may be removed before or after stapling. In some embodiments,the cross-sectional area of the IA 20 in the resulting sleeve may bemaintained or increased in comparison with a sleeve formed by priormethods that may cause a narrowing in the cross-sectional area of the IA20.

According to one embodiment, the shaping portion 104 may be integrallyformed as a unitary monolithic structure as part of the tube portion102, for example, during manufacturing. In additional or alternativeexamples, the shaping portion 104 may be separately coupled and/orfixedly attached to the tube portion 102 and/or may include multipleseparate pieces. The shaping portion 104 may be unitary or may besegmented. In various embodiments, the one or more balloons 114 can becompliant, semi-compliant, noncompliant, or combinations thereof. If theshaping portion 104 is segmented, each segment may vary in shape andsize.

In use, the shaping portion 104 may be placed relative to one or moredesired anatomic landmarks. The desired landmark may vary based on thetype of first medical device or application. Examples of desiredlandmarks include the incisura angularis 20, the pylorus 14, and thegastroesophageal (GE) junction 18. The shape of the shaping portion 104may vary based on the desired landmark. In various embodiments, theshaping portion 104 may be a cylinder positioned at the incisuraangularis 20, a frustrum positioned at the pylorus 14, or a long cone orteardrop shape that can be considered a sleeve mold, although the shapesare not so limited.

In an embodiment, the system may include one or more fluid circuits,such as a fluid delivery system, to provide positive pressure to theshaping portion and/or the stomach lumen. One or both of the tubeportion 102 and the shaping portion 104 may be coupled to a fluid sourcesuch as a foot pump or hand pump. For example, the tube portion 102 maydefine a lumen 120 extending between a distal aperture 122 or distallumen end and a proximal aperture 124 or proximal lumen end. When inuse, the distal aperture 122 may open into the stomach lumen, and theproximal aperture 124 may be coupled to a fluid source (e.g., via aconnecting tube 126). The tube portion 102 may also define a lumen 128fluidically coupling the interior of the balloon 114 (e.g., via anaperture 130) and a fluid source (e.g., via a coupling 132). The fluidmay be a gas (e.g., ambient air, central air, CO₂, or nitrogen) or aliquid (e.g., an aqueous solution, such as saline, or water). Where thetube portion 102 and the shaping portion 104 are coupled to separatefluid sources, the fluid sources may be the same or different. Asdescribed below, components other than the first medical device 100 maybe coupled to a fluid circuit.

In various embodiments, the one or more fluid circuits or fluid deliverysystems may be coupled to a pump system. For example, the tube portion102, the shaping portion 104, and/or a separate catheter incommunication with the stomach lumen can be coupled with a pneumaticpump to provide positive pressure and/or suction. For example, as shownin FIG. 3 , a system including a multi-lumen catheter (e.g., the tubeportion 102) is coupled to an inflation pump 134 and a suction pump 136through a three-way valve 138. The pumps 134, 136 may be controllable bymechanical means, such as an inflation foot pedal 139 and a suction footpedal 140. The pump may also be configured to control suction. Suitablepumps include, without limitation, a foot pump, a hand pump, an electricmotor pump, or a combination thereof. A mechanical foot pump mayinclude, for example, a bellows and one or more pedals. A hand pump mayinclude a stopcock that may be turned after clamping. A motorized pumpmay include switches or pedals for positive pressure or suction. In anexample, the pump system may include a pump configured to apply bothinflation and suction. As shown in FIG. 4A, a system including amulti-lumen catheter (e.g., the tube portion 102) is coupled to a pump142 through a three-way valve 138. The three-way valve 138 may be a partof the pump 142 or a separate component. The pump 142 may becontrollable by mechanical means, such as a foot pedal 144. Although onepedal 144 is shown and may be configured to control both suction andinflation, more than one may be included. FIG. 4B illustrates anembodiment including a first and second fluid delivery system. The firstfluid delivery system is coupled to the tube portion (e.g., lumen 120)including a sensor 160, a hand pump 134 (see FIG. 4C), and a sensor 160.The second fluid delivery system includes an inflation/suction pump 142and a sensor 160 coupled to the balloon 114 of the shaping portion. FIG.4C depicts an example hand pump 134 including a bulb 134 a coupled to a2-way stopcock 134 b via tubing 134 c. The 2-way stopcock 134 b is alsocoupled to an adapter 134 d to be connected to a suction source and anadapter 134 e to be coupled to the first medical device 100. The handpump 134 may also include a pressure gauge 134 f. Alternative to pedals,in an embodiment, buttons may be incorporated into the second medicaldevice 300 to inflate and deflate the stomach, as discussed furtherbelow.

The pump 142 can be associated with a monitor or control system for themonitoring and metering of the fluid to be delivered such that thestomach is not overinflated. The monitor can include a visual or audibleindicator of when the stomach pressure or stomach volume if, forexample, above a desirable predetermined range, below a predeterminedrange, or within the predetermined range. The monitor or control systemcan include a release valve set at a pressure above the desirablepredetermined range to offgas fluid to return the stomach volume orpressure to an acceptable range. The control system may include anysuitable features to provide a constant volume or pressure within thestomach, which may differ from prior techniques that insufflate thestomach to test for leaks and the like. Prior insufflation testingmethods may use relatively high pressures, such as above 25 mmHg, totest for leaks without the need to meter or maintain such a pressurewithin a defined range. Such pressures in insufflation testapplications, which can exceed 50 mmHg to 75 mmHg may be too high foruse with the presently described systems. Embodiments described hereincan include suitable feedback sensors and the like with the firstmedical device or bougie to allow the control system to adjust pressureor volume in accordance with embodiments described herein.

In an embodiment, the first medical device may be configured to maintaina higher pressure in the shaping portion 104 than the stomach lumenduring the sleeve gastrectomy procedure. The maximum pressure of theshaping portion 104 may be in a range of, for example, 40 mmHg to 70mmHg. The maximum pressure of the stomach lumen may be, for example, upto 20 mmHg (the physiologic ‘pain’ pressure of the stomach), in a rangeof about 20 mmHg to about 100 mmHg, or up to 100 mmHg. If the surgery isbeing performed laparoscopically, the pneumoperitoneum will need to beaccounted for (e.g., 10 mmHg to 20 mmHg). This pressure allows thestomach to inflate but not be unnaturally deformed. Further, the tensionprovided by the pressure has a direction and magnitude natural to thestomach tissue. The tension relieves the surgeon from the necessity ofmanipulating the tissue and potentially disrupting the natural tensionpattern of the stomach tissue, although the surgeon may still manipulatethe tissue manually if desired. The direction of the tension vector isgenerally at a right angle to the longitudinal axis of the secondmedical device 300 (e.g., longitudinal axis of the jaws 302, 304), whichmay provide a better resection line. The pressure used to inflate theshaping portion 104 may vary. In an example, the pressure used toinflate a balloon with water may be about 115 mmHg.

Referring now to FIGS. 5A-5E, an example method or procedure that may beperformed using the first medical device 100 and second medical device300 is shown. In an example method of creating a sleeve gastrectomy, thefirst medical device 100 is inserted in a stomach 12. The first medicaldevice 100 is placed along the lesser curvature 16 adjacent to one ormore desired anatomic landmarks. Next, a second medical device 300, suchas a full-length 23 cm clamp or stapler, is placed across the length ofthe stomach (FIG. 5A). The lumen 120 is connected to positive pressure.The positive pressure may be applied to begin inflating the stomach(FIG. 5B). The positive pressure generates the most tension in thewidest portion of the stomach according to the Law of Laplace (T=PR).The first medical device 100 may also include a shaping portion 104 thatis inflated using positive pressure. Methods of controlling andmonitoring the positive pressure are described above.

Once more than half of the inflated stomach radius resides lateral tothe second medical device 300 (i.e., in a direction away from the firstmedical device 100), the balloon-like stomach urges the second medicaldevice 300 to become adjacent and snug against the shaping portion 104of the first medical device 100. As the stomach inflates (FIG. 5C), thegrowing pressure in the larger portion of the stomach causes the secondmedical device 300 to move towards the first medical device 100 andpushes the tissue between the first and second medical devices 100, 300against the shaping portion 104, while uniform tension is applied to thestomach wall. The tissue along the lesser curvature 16 of the stomachmay also be drawn towards the shaping portion 104. If too much tissuemoves to the remnant side of the stomach due to the increasing pressure,the pressure may be reduced manually or automatically to allow propersizing of the desired sleeve before clamping. If desired, the surgeonmay manipulate the tissue during inflation to control the shape and sizeof the resulting sleeve. The second medical device 300 may then bepartially or fully clamped (FIG. 5D). The stomach lumen may be suctioned(FIG. 5E) before or after fully clamping the second medical device 300.The first medical device 100 may be removed from the stomach afterclamping but before stapling. If the stomach is suctioned, positivepressure may be reintroduced to perform a leak test. The stomach may bestapled and cut (i.e., resected) along the resection line defined by thesecond medical device 300. Embodiments herein may allow for stapling andcutting along a straight resection line while the resulting sleeve iscurved along the staple line. While examples herein may describe thesecond medical device 300 as a full-length stapler, the disclosure isnot so limited. In an embodiment, the second medical device is aless-than-full-length stapler. The first activation of the stapler maybe done before or after the positive pressure is applied to the stomachlumen. The stapler may then be advanced across the length of the stomachwhile the stomach is inflated. The first medical device 100 acts as aguide to the surgeon.

Laplace retraction allows for each ‘rope’ or ‘elastic band’ of thestomach to be pulled in the correct direction as the positive pressureprovides tension along the natural stomach distension vectors,preventing the surgeon from having to manually manipulate the stomach(e.g., using a laparoscopic grasper) in an attempt to create the desiredtension. The pressure also pulls every gastric fiber simultaneously, notrelying on the segments of tissue that a laparoscopic grasper can grabat one time. Additionally, if the second medical device 300 wasinitially positioned over a folded piece of stomach, the positivepressure can flatten out all parts of the stomach, preventing theclamping/stapling of folded stomach. Stapling folded stomach tissue canlead to staple line failure and leak. The resultant sleeve may have, forexample, a diameter of 1 to 3 cm near a first landmark (e.g., the IA), 2to 6 cm near a second landmark (e.g., the size of the antrum measuredfrom the pylorus), and 0 to 2 cm near a third landmark (e.g., measuredfrom the edge of the GE junction notch) of the stomach. In anotherexample, the resultant sleeve may have a diameter of 1 cm to 2 cm at thefundus, a diameter of 2 cm to 3 cm at the body at the incisuraangularis, and a diameter of 3 cm to 6 cm at the antrum.

With reference to FIGS. 6A-6C, in various embodiments, the first medicaldevice 100 may be configured to provide suction. The first medicaldevice 100 may include a lumen opening to the outside of the firstmedical device 100 (e.g., lumen 120). One or more suction apertures maybe distributed along the length of the catheter. Alternatively, thelumen may extend through the first medical device 100, and suctionopenings may be provided at a distal end of the lumen. The first medicaldevice 100 or other component providing suction may include a suctioncontrol valve that may be used to regulate when and how suction may beapplied. Embodiments may incorporate the serial or simultaneous use ofsuction and inflation to create a desired sleeve geometry.

With further reference to FIGS. 6A-6C, in some embodiments, the shapingportion 104 may include an area in communication with the stomach lumenconfigured to allow for inflation or suction between two balloons 114.For example, the shaping portion 104 may include a first balloon 114 aand a second balloon 114 b separated by a section of the tube portion102. The shape of the first and second balloons 114 a,b may be the sameor may be different. In an example embodiment, the first balloon 114 amay have a tapered shape (e.g., conical frustum shape) and the secondballoon 114 b may have, for example, a disc shape. When positioned inthe stomach, the first balloon 114 a may extend from the GE junction 18to the IA 20, and the second balloon 114 b may be adjacent the antrum22. The section of the tube portion 102 between the first and secondballoons 114 a,b may be in communication with the stomach lumen. Forexample, as shown in FIG. 6A, the section may include suction apertures146, such as holes, mesh, or other porous features, that allow air topass in and out of the tube portion 102. The tube portion 102 may havemultiple lumens including, in an embodiment, a lumen coupling the holes,mesh, or other porous features with an inflation and/or suction pump(e.g., lumen 120). Referring to FIG. 6B, in an embodiment, one or bothof the balloons 114 a,b may also include suction apertures 148 and becoupled to a suction pump. Additionally, the section of the tube portion102 between the first and second balloons 114 a,b may also be coupled toa pump capable of applying positive pressure in addition to applyingsuction. In an embodiment, as shown in FIG. 6C, a section of the tubeportion 102 distal of the second balloon 114 b may include suctionapertures 150. The suction apertures 150 may be independently operablefrom the suction apertures 146. For example, suction may be appliedthrough the suction apertures 150 while positive pressure is appliedthrough the suction apertures 146 or vice versa.

Still referring to FIGS. 6A-6C, suction may be applied to the sectionbetween the first and second balloons when the balloons are in adeflated state, an inflated state, or when the balloons aretransitioning between those two states. For example, suction may beapplied between the first and second balloons 114 a,b to help bringtissue closer to the first and second balloons 114 a,b while the stomachlumen is being inflated and the second medical device 300 is being urgedby the balloon-like stomach to become snug against the first medicaldevice 100. In another example, suction may be applied between the firstand second balloons 114 a,b to help deflate the stomach lumen before thesecond medical device 300 has been clamped or the lumen of the desiredsleeve after the second medical device 300 has been clamped.

In some embodiments, an additional catheter or other tube separate fromthe first medical device 100 is in fluid communication with the stomachlumen. The catheter may provide positive pressure in the stomach lumen.In various embodiments, the catheter may also be configured to provide asuction force. For example, a needle may be inserted into the portion ofthe stomach to be removed during the gastrectomy procedure (“remnantportion”), where the needle is coupled to a pump capable of suctionand/or inflation. A grasper may be used to control the position of thestomach, for example, when a catheter or needle is inserted other thanthrough the esophagus.

Referring now to FIG. 7 , in some embodiments, the first medical device100 may include an overtube 152. The overtube 152 can be more rigid thanthe shaping portion 104 and may be slid over the exterior of the shapingportion 104. The overtube 152 may be used during insertion of the firstmedical device 100 into the stomach. In an embodiment, the overtube 152is flexible enough to act as an introducer sheath. Additionally, in someembodiments, the overtube 152 may optionally include peel-away handles154 for the surgeon or other user to pull. The handles 154 can be smallfinger grips, such as those commonly used on transcathetercardiovascular devices, which allow the overtube 152 to be removed bypulling it back. The peel-away function can allow the overtube 152 toslide back over a catheter bifurcation hub. If the overtube 152 is stillpositioned on the shaping portion 104 when it is inflated, the overtube152 can alter the shape and pressure distribution of the shaping portion104. The overtube 152 may be used to ensure that the stapler ispositioned about 1 cm from the GE junction 18 at the top of theresection line.

With reference to FIGS. 8A and 8B, in some embodiments, the firstmedical device 100 is configured to allow another device, such as agastroscope 156, to pass through the first medical device 100. Forexample, the gastroscope 156 may extend through the lumen 120 of thefirst medical device 100 and out of the distal aperture 122 (FIG. 8A).In another embodiment, the first medical device 100 may include achannel 158 extending through a portion or the entirety of the lengththrough which the gastroscope 156 may pass (FIG. 8B). The channel 158may be coextensive with the lumen 120. Although not shown in FIG. 8B, inan embodiment, the first medical device 100 may include a separate lumenopening to the stomach lumen to control the pressure therein.

In various embodiments, the system may include one or more sensors 160,such as pressure sensors, flow sensors, volume sensors, etc. The sensorsmay be digital or mechanical. A sensor may be an in-line sensor. Asuitable example pressure sensor is a 0-5 psi Omega™ digital pressuretransducer (PX26-005GV). The one or more sensors may include a displayor may be in communication with a display 400, monitor, or controlsystem, such as one discussed below. For example, mechanical sensors mayuse a spring or column of fluid to display the measured pressure (e.g.,stomach pressure, back-pressure on the inflated shaping portion,suction, etc.). The display may include an indicator to identify whetherthe measured pressure is low, high, or in an acceptable range. Forexample, a color-coded range can be used to correlate the measuredpressure or volume in the stomach lumen to the desired tension of thestomach tissue.

In various embodiments, any sensor(s) can communicate data via awireless or wired connection one or more of the first medical device,the second medical device, or a remote device, such as a display. Forexample, information collected by the sensor(s) can be transmitted usingwireless connections (e.g., Bluetooth, Wi-Fi, a cellular network, asatellite, etc.) or wired connections (e.g., cable, copper or fiberoptics, etc.).

The system, in some embodiments, may be configured to control or detecta volume of inflation. As discussed above, the system may include amonitor or control system for the monitoring and metering of the fluidto be delivered. The volume of inflation detected and/or controlled maybe the volume of the stomach lumen and/or the volume of the shapingportion. Ultimately, the volume of the resultant sleeve may also becontrolled. The fluid source may be a syringe or other container with aknown volume of fluid. For example, a 60 mL or 100 mL syringe may beused as a fluid source for the inflation of the stomach lumen. The fluidsource may be configured to provide an indication of the volume of fluidused to inflate the stomach lumen (e.g., measurements on a syringe orcontainer). In another embodiment, the pump may be used to applydiscrete volumes of fluid. A hand pump, for example, may have a knownvolume of fluid per application (e.g., squeeze). As another example, anelectric pump may have a known flow rate, and the system may beconfigured to detect the volume used based on the time the pump wasactivated. In some embodiments, a flow meter or flow sensor may be usedto measure the flow of fluid into the stomach lumen. Where a compressedfluid (e.g., compressed air) is used as a fluid source, the system maybe configured to measure a pressure drop (e.g., with a pressure sensor)in the compressed fluid container to determine the volume of fluid used.The system may also include, in example embodiments, an integrated valvethat discontinues fluid flow when a predetermined volume in the stomachlumen is reached. In an embodiment, the integrated valve may be incommunication with the controls or a sensor.

In some embodiments, the system will include controls 402 forcontrolling the inflation and/or suction. For example, one or more ofthe first medical device 100, the second medical device 300, or a remotedevice may include controls in wireless or wired communication with thepump system. In an embodiment, the controls 402 can include a monitor orcontrol system for the monitoring and metering of the fluid to bedelivered as discussed above. In an embodiment, the second medicaldevice 300 includes switches or buttons to control the inflation and/orsuction of the balloon and inflation and/or suction inflation of thestomach lumen. The controls 402 may include, for example, a power buttonor a “zero” or tare button.

In various embodiments, the system may include a display 400. Thedisplay 400 may be configured to show data, such as pressure datarelating to the shaping portion and/or the stomach lumen. The display400 may be on one of the first medical device 100, the second medicaldevice 300, or a separate display device. In an embodiment, the displaydevice may include controls (e.g., controls 402) in wireless or wiredcommunication with the inflation/suction system. The display 400 mayalso be configured to show data history (e.g., in a graph updating inreal-time) or recent changes in the data. In an embodiment, the displaydevice may have a hook or a handle. For example, the display device maybe hangable from an IV pole. The display, in some embodiments, may be incommunication with a camera and be configured to show the video feed(e.g., from gastroscope 156). In another embodiment, the display devicemay be a remote device such as a mobile phone or computer. The display400 may include an indicator 404 to identify whether the measuredpressure is low, high, or in an acceptable range. For example, acolor-coded range can be used to correlate the measured pressure in thestomach lumen to the desired tension of the stomach tissue. The display400 may be configured to provide a signal, such as an audio or visualsignal. A signal may be provided for various reasons, such as when thetissue tension is at a predetermined value, if there is too muchtension, if there is too little tension, etc.

In some embodiments, the relative maximum pressure of the shapingportion and the stomach lumen may be controlled based on the materials,dimensions, resistance, and fluid flow rates of the system. The systemcan include one or more relief valves 162. Additionally oralternatively, in an example embodiment, the first medical device 100may include a first relief valve, such as a pop-off or check valve, setat a predetermined maximum pressure of the shaping portion 104. In anembodiment, the first relief valve may be in fluid communication withthe lumen of the stomach as well as the lumen of the shaping portion104. For example, the first relief valve may open into a lumen thatopens into the stomach lumen. The first relief valve may vent the excessfluid into the lumen of the stomach. In this configuration, the shapingportion 104 will fill with fluid until the maximum pressure is reachedcausing additional fluid to vent into the stomach lumen, thus increasingthe pressure in the stomach lumen. Due to the first relief valve, theshaping portion 104 maintains a higher pressure than that in the stomachlumen. Further, in some embodiments, the first medical device 100 orother component providing inflation may include a relief valve toprevent over-pressurization of the stomach lumen. The second reliefvalve may be set to a predetermined maximum pressure of the stomach. Thepredetermined maximum pressure of the stomach lumen is lower than thepredetermined maximum pressure of the shaping portion. A suitableexample of a relief valve is a flutter valve (a.k.a. duckbill orHeimlich valve). In some embodiments, a relief valve may provide anindication (e.g., audible or visible) that the predetermined pressurehas been reached (e.g., maximum balloon pressure or maximum pressure inthe stomach lumen).

In some embodiments, techniques or devices may be used to move more ofthe antrum to the remnant portion than would otherwise exist due to thepositive pressure in the stomach lumen alone. The size of the antrum inthe desired sleeve may be actively reduced. In an embodiment, the secondmedical device may be partially clamped on a bottom part of the stomach(i.e., distal relative to the first medical device, proximal relative tothe second medical device). For example, the proximal end of the secondmedical device may be clamped from the bottom end of the stomachextending upwardly along a portion of the antrum, while the distal endof the second medical device remains unclamped. The shaping portion ofthe first medical device may be inflated or expanded before the first,partial clamp is made. The location of the partial clamp may bedetermined based on the desired size of the antrum in the resultingsleeve. The second medical device may be repositioned or angled suchthat the distal end of the second medical device is near the GEjunction. The stomach lumen may be inflated as described above. Thesecond medical device may be urged against the first medical device, andthe remainder of the second medical device may then be clamped.Partially clamping the proximal end of the second medical device beforeinflating the stomach lumen allows for precise control of the size ofthe antrum in the resulting sleeve.

In another example embodiment, a bottom portion of the stomach may bestapled along the resection line before the stomach lumen is inflated.For example, the bottom end of the stomach extending upwardly along aportion of the antrum may be stapled. The location of the resection lineand stapling may be determined based on the desired size of the antrumin the resulting sleeve. The bottom portion of the stomach may bestapled using the second medical device or a separate stapler. Theshaping portion of the first medical device may be inflated or expandedbefore the initial stapling. Afterwards, the second medical device maybe positioned or angled such that the distal end of the second medicaldevice is near the GE junction. The stomach lumen may be inflated asdescribed above. The second medical device may be urged against thefirst medical device, and the remainder of the second medical device maythen be clamped. The remainder of the stomach along the resection linemay be stapled. Partially stapling the bottom end of the stomach beforeinflating the stomach lumen allows for precise control of the size ofthe antrum in the resulting sleeve. Due to the partial stapling at thebottom of the stomach, the resection line may not be a straight line.

With reference to FIG. 9 , in some embodiments, a connector 406 may becoupled to two segments of the stomach to pull the antrum through thesecond medical device 300. For example, a connector 406 may be coupledat one end 408 to a first section of the stomach (e.g., the fundus 24 orbody 26 adjacent or along the greater curvature 28) and at the other end410 to the antrum 22 (e.g., adjacent or along the greater curvature 28).When the stomach inflates, the first section of the stomach will expandfurther than the antrum due to the increased volume in the firstsection. As the first section continues to expand, the connector willpull the antrum tissue along with the first section resulting in asmaller portion of the antrum remaining in the desired sleeve (e.g., tothe right of the second medical device). The connector can be rigid(e.g., a suture) or a semi-compliant material. For example, theconnector 406 can be an elastomeric material or spring element capableof being anchored to the stomach (e.g., with surgical clips or othermechanical means) either integrated into the connector 406 or applieddirectly to the connector 406. The connector 406 can be implantable orremovable; it will be removed with the remnant portion of the stomach.

In various embodiments, the distal end 306 of the second medical device300 may be initially clamped from the top end of the stomach (e.g.,approximately 1 cm from the GE junction) extending downwardly along aportion of the stomach, while the proximal end 308 of the second medicaldevice 300 remains unclamped. The top end of the stomach may be clampedwhile the shaping portion 104 of the first medical device 100 isinflated or expanded and while the stomach lumen is inflated. Thepressure in the stomach lumen may be increased after the top end of thestomach is clamped. In an embodiment, the positive pressure in thestomach lumen may be in a range of about 1 mmHg to about 5 mmHg when thetop of the stomach is partially clamped, and the pressure may beincreased to be in a range of about 20 mmHg to about 25 mmHg. Forexample, the pressure after the top end of the stomach is clamped may beincreased to about 20 mmHg or about 25 mmHg. The direction of expansionof the stomach will be affected by the partial clamp at the top of thestomach. The antrum 22 will expand further due to the increased pressurecausing more of the tissue to move through the second medical device 300to the remnant side. Once the desired amount of antrum 22 remains in thesleeve, the second medical device 300 may be fully clamped. Partiallyclamping the distal end 306 of the second medical device 300 beforeinflating the stomach lumen further allows for precise control of thesize of the antrum 22 in the resulting sleeve.

In some embodiments, the proximal end 112 of the intragastric section110 of the first medical device 100 may be configured to anchor thetissue at the top end of the stomach. For example, the first medicaldevice 100 may be configured to provide suction at or near the proximalend 112. The suction may allow the first medical device 100 to hold theadjacent tissue in place. While the shaping portion 104 of the firstmedical device 100 is inflated or expanded and while the stomach lumenis inflated, the top end of the stomach may be suctioned to the proximalend 112 of the first medical device 100. In an embodiment, the negativepressure used to hold the stomach tissue in place may be in a range ofabout 20 mmHg to about 200 mmHg, in a range of about 115 mmHg to about135 mmHg, or about 125 mmHg. The pressure in the stomach lumen may beincreased after the top end of the stomach is anchored in place. In anembodiment, the positive pressure in the stomach lumen may be in a rangeof about 1 mmHg to about 5 mmHg when the top of the stomach issuctioned, and the pressure may be increased to be in a range of about20 mmHg to about 25 mmHg. For example, the pressure after the top end ofthe stomach is suctioned in place may be increased to about 20 mmHg orabout 25 mmHg. The direction of expansion of the stomach will beaffected by the suction at the top of the stomach. The antrum 22 willexpand further due to the increased pressure causing more of the tissueto move through the jaws 302, 304 of the second medical device 300 tothe remnant side. Once the desired amount of antrum 22 remains in thesleeve, the second medical device 300 may be clamped, and the suction atthe proximal end 112 of the first medical device 100 may bediscontinued. Anchoring the top end of the stomach before inflating thestomach lumen further allows for precise control of the size of theantrum 22 in the resulting sleeve. Examples of suction being applied bythe first medical device 100 are described herein (e.g., FIGS. 6B, 6C,and 10 ).

In various embodiments, the stomach may be overinflated such that aportion of the first medical device 100 moves partially through the jaws302, 304 of the second medical device 300 before the second medicaldevice 300 is clamped. Initially, the second medical device 300 is in anopen position, and the stomach lumen is inflated. The pressure in thestomach lumen is increased until the tissue along the lesser curvature16 of the stomach is tensioned to the point where it pushes at least aportion of the first medical device 100 through the open jaws 302, 304of the second medical device 300. For example, a middle portion of theintragastric section 110 of the first medical device 100 may movethrough the jaws 302, 304. The pressure in the stomach lumen is thenreduced, allowing the first medical device 100 to return to the right(or the sleeve side) of the second medical device 300. The shapingportion 104 of the first medical device 100 is then inflated orexpanded. The pressure in the stomach lumen is increased to urge thesecond medical device 300 against the first medical device 100, asdescribed above, and then clamped. When the stomach was inflated to thepoint where the first medical device 100 partially moves through theopen jaws 302, 304, tissue from the antrum 22 also moves through thejaws 302, 304 to the remnant side. This process may result in moreantrum tissue in the remnant side than would otherwise exist.

In various embodiments, the first medical device 100 may be configuredto anchor a section of the antrum 22 to a distal portion of the firstmedical device 100. Afterwards, the distal portion of the first medicaldevice 100 may be moved towards the second medical device 300. Forexample, the first medical device 100 may be configured to applysuction, for example, at a distal portion thereof. An example embodimentis described above in reference to FIG. 6B. As shown in FIG. 10 , in anembodiment, the first medical device 100 may include mesh 164 (or othersuction apertures) coupled by a lumen 166 to a pump. In an embodiment,the mesh 164 may be about 30 mm to about 70 mm from the distal tip. Themesh 164 may begin, in some embodiments, at the distal end 108 of thetube portion 102. In an embodiment, the mesh 164 may extend about 21 cmfrom the distal end 108. The mesh 164 may be continuous or segmented.The pump may apply a negative pressure through the lumen 166 causingtissue adjacent to the mesh 164 to be suctioned against the mesh 164. Inan embodiment, the negative pressure used to hold the stomach tissue inplace may be in a range of about 20 mmHg to about 200 mmHg, in a rangeof about 115 mmHg to about 135 mmHg, or about 125 mmHg. The suction mayanchor the tissue, such as antrum tissue, to the distal portion of thefirst medical device 100. As described further below, the distal portionof the first medical device 100 may be moved towards the second medicaldevice 300 before the second medical device 300 is clamped, which allowsfor more precise control of the size and shape of the resulting sleeve.

Still referring to FIG. 10 , the first medical device 100 may include anarticulating tip 168 in various embodiments. The first medical device100 may include an elongate arm 170 including a plurality of ribs 172.The ribs 172 define a plurality of spaces 174 that allow the elongatearm 170 to bend in at least one direction. The first medical device 100also includes a tensioning element 176 coupled to a distal portion ofthe elongate arm 170. The tensioning element 176 may be flexible, suchas a wire, thread, rod, etc. In an embodiment, the tensioning element176 extends through the ribs 172, as well as the spaces 174 between theribs 172. The elongate arm 170 and/or the tensioning element 176 mayextend through a conduit 178 that extends through the tube portion 102.For example, the proximal end of the tensioning element 176 may extendout of the tube portion 102 to be manipulated by a surgeon. The distalend of the tensioning element 176 may move between a first position anda second position. For example, the distal end of the tensioning element176 may be pulled proximally from the first position to the secondposition, which causes the ribs 172 to move closer to one another (i.e.,the spaces 174 between the ribs 172 become smaller or disappear). Thesecond position of the articulating tip 168 is shown in dashed line inFIG. 10 . When the tensioning element 176 is allowed to move distallytowards its first position, the ribs 172 move away from each other(i.e., the spaces 174 between the ribs 172 become larger). Those skilledin the art will appreciate that other articulating techniques may beused.

For clarity purposes, a shaping portion 104 is not shown in FIG. 10 ,although it is contemplated that the mesh 164 may be distal of theshaping portion 104 or may extend over the shaping portion 104. Forexample, in an embodiment, the mesh 164 may cover at least a portion ofa balloon 114 and may be flexible such that it expands when the balloon114 is inflated. Additionally, as discussed above, the first medicaldevice 100 may also include a lumen (e.g., lumen 120) that is configuredto control inflation of the stomach lumen. In use, the first medicaldevice 100 may be inserted into the stomach lumen. The articulating tip168 may be tensioned such that the articulating tip 168 bends towardsthe lesser curvature 16 of the stomach. Suction may be applied to themesh 164 to anchor antrum tissue to the articulating tip 168. Suctionmay be applied before or after the shaping portion 104 is inflated orexpanded. Inflating or expanding the shaping portion 104 after thetissue has been anchored may help move the antrum tissue further due tothe changing shape of the shaping portion 104. The articulating tip 168may then be released to its first position. As the articulating tip 168moves away from the lesser curvature 16 (i.e., towards the secondmedical device 300), the anchored tissue of the antrum 22 moves at thesame time. The stomach lumen may then be inflated to urge the secondmedical device 300 against the first medical device 100, and the secondmedical device 100 may be clamped. As described above, anchoring theantrum tissue and moving it towards the second medical device 300 allowsfor more precise control of the size of the antrum in the resultingsleeve.

In addition or alternative to the articulating tip 168 described above,various techniques may be used to straighten the first medical deviceafter tissue has been anchored to it. In an embodiment, the shapingportion of the first medical device may be a non-compliant balloonmaterial (e.g., nylon, polyester, etc.) or a semi-compliant balloonmaterial (e.g., Pebax®, high-durometer polyurethane, etc.). Initially,while the shaping portion 104 is deflated, the tube portion 102 isinserted into the stomach and positioned against the lesser curvature 16of the stomach through tissue manipulation. The balloon 114 may beuninflated or inflated to a low or medium pressure before suction isapplied at the distal portion to anchor the tissue. In an embodiment,the initial low or medium pressure may be enough pressure to demonstratethe correct sleeve size but not enough to straighten out the balloon114. After the tissue is anchored, the balloon may be inflated to a highpressure, which may straighten the balloon 114 and moves the antrumtissue further through the jaws 302, 402. A non-compliant orsemi-compliant balloon may be used, for example, in combination with anarticulating tip 168 as described above.

In some embodiments, an additional device may be used to straighten thefirst medical device after tissue has been anchored to it. As shown inFIGS. 11A and 11B, in an example embodiment, the first medical device100 may have a naturally curved distal portion, and a stylet 412 may beinserted through the first medical device 100 to straighten or move thecurved portion towards the second medical device 300. In use, the firstmedical device 100 may be inserted into the stomach lumen where thedistal portion curves toward the lesser curvature 16 of the stomach. Thetissue, such as antrum tissue, may be anchored to the distal portion(e.g., using suction as described above). A stylet 412 or other rigidcomponent (e.g., more rigid than the tube portion 102) may be insertedthrough the first medical device 100. As the stylet 412 enters thedistal portion of the first medical device 100, the distal portion willstraighten out or move towards the second medical device 300 (as shownin FIG. 11B). As described above, anchoring the antrum tissue and movingit towards the second medical device 300 allows for more precise controlof the size of the antrum 22 in the resulting sleeve.

In various embodiments, techniques other than suction may be used toanchor tissue to a portion of the first medical device. As shown inFIGS. 11A and 11B, in an embodiment, an anchor 180 may be positioned ona distal portion of the first medical device 100. The anchor 180 may beconfigured to “grab” adjacent tissue (e.g., the mucosa). The anchor 180may include, without limitation, hooks (e.g., similar to those used inhook-and-loop fasteners), a barb, a clip, a magnet, a suture, or acombination thereof. An overtube or introducer sheath may be used wheninserting a first medical device 100 including an anchor 180, which canreduce the chance of unintentionally anchoring tissue before the firstmedical device is in proper position 100.

In various embodiments, alternative techniques may be used to applysuction to anchor tissue to a portion of the first medical device. Asshown in FIGS. 12A-12C, the first medical device 100 may include aperforated sheath 182. The perforated sheath 182 may extend from thedistal end 108 of the first medical device 100 proximally along a lengthof the first medical device 100. Suction apertures 184 (e.g., holes, orother openings, e.g., mesh) may be positioned along a portion or anentirety of the perforated sheath 182. In example embodiments, theperforations can extend between about 30 mm to about 70 mm from thedistal end or about 21 cm from the distal end. The perforations maybegin, in some embodiments, at the distal end of the perforated sheath182. In an embodiment, the perforations may extend about 21 cm from thedistal end of the perforated sheath 182. The perforated sheath 182 maybe continuous or segmented. The suction apertures 184 are coupled to apump. The perforated sheath 182 may extend over the shaping portion 104or a portion thereof. At least a portion of the perforated sheath 182may be flexible or expandable such that, when the shaping portion 104 isinflated or expanded, the adjacent portions of the perforated sheath 182also expand (FIG. 12B). In an embodiment, as shown in FIG. 12C, theperforated sheath 182 may include grooves 186 (e.g., channels or otherlumens) coupling the suction apertures 184 to the pump. The grooves 186may be rigid to maintain the connection between the suction apertures184 and the pump when the perforated sheath 182 is expanded by theshaping portion 104. In other words, the expansion of the shapingportion 104 does not cause the grooves 186 to collapse thereby cuttingoff the suction. After the antrum tissue is anchored to the firstmedical device 100 by suction, the distal portion of the first medicaldevice 100 may be moved towards the second medical device. For example,the first medical device may include an articulating tip 168 or a stylet412 may be used, as discussed above. An overtube, such as overtube 152,may be positioned over the perforated sheath 182. For example, anovertube may be used as an introducer sheath when inserting or removingthe first medical device 100 from the stomach lumen.

In addition or alternative to the suction or anchors described above,various techniques may be used to anchor tissue to a portion of thefirst medical device. In various embodiments, a temporary solubleadhesive coating may be included on a portion of the first medicaldevice (e.g., on a portion of a balloon that, when expanded, is adjacentthe antrum). In other embodiments, a temporary soluble adhesive may beexuded through pores on the first medical device. As shown in FIG. 13 ,in another embodiment, the first medical device 100 may include aninflatable or expandable portion 188 in addition to and separate fromthe shaping portion 104 (not shown). The inflatable or expandableportion 188 may be extended through the pyloric sphincter 30 andinflated or expanded such that it cannot be easily removed through thepyloric sphincter 30. As the distal portion of the first medical device100 is moved towards the second medical device 300, the inflatable orexpandable portion 188 pulls the pyloric sphincter 30 and thesurrounding tissue in the same direction. It will be appreciated thatany techniques described herein to anchor tissue to the first medicaldevice may be used with techniques described herein to move a portion ofthe first medical device toward the second medical device. It will alsobe appreciated that other techniques may be used to perform theanchoring or the movement.

In some embodiments, inflation of the stomach may be at least partiallycontrolled from the desired remnant portion of the stomach. For example,a needle may be inserted in the stomach lumen on the opposite side ofthe second medical device 300 from the first medical device 100 (e.g.,through the fundus 24 or body 26 near the greater curvature 28) to applyinflation or suction. As shown in FIGS. 14A and 14B, in anotherembodiment, an inflatable or expandable component, such as a balloon414, may be inserted into the stomach lumen on the opposite side of thesecond medical device 300 from the first medical device 100. The balloon414 may be inserted through a needle 416 or catheter. The balloon 414may be inflated to urge the second medical device 300 towards the firstmedical device 100. In an embodiment, the shape of the balloon 414 maybe determined based on the shape of the desired sleeve. For example, theportion of the balloon 414 adjacent the antrum 22 may be shaped to movea desired portion of the antrum tissue through the jaws 302, 304 of thesecond medical device 300. Graspers 418 may be used to control thestomach to prevent unintentional injury (e.g., unintentionally pullingout the needle 416 before the balloon 414 is fully deflated).

In various embodiments, the system may use dynamic feedback. The systemmay be configured, in some embodiments, to automatically controlpressurization of the stomach lumen based on the feedback. As anexample, the system may use dynamic feedback to determine when to clampthe second medical device. The second medical device may be clampedmanually or automatically based on the feedback. In an embodiment, asshown in FIG. 15 , the shaping portion 104 can include one or moresegments 104 a. Each segment 104 a of the shaping portion 104 may becoupled with a fluid source, for example, through separate lumens (e.g.,lumen 128). Each segment 104 a may also be in communication with one ormore sensors 160 (e.g., shown in FIGS. 4A and 4B), such as a pressuretransducer coupled to the respective fluid source or lumen. After thefirst medical device 100 is positioned in the stomach, each segment maybe independently filled with a fluid under pressure. A catheter incommunication with the stomach lumen (e.g., part of the first medicaldevice 100 or a separate component as described above) is coupled to apump. Fluid is introduced to the stomach lumen thus increasing thepressure and tension according to the Law of Laplace, as describedabove.

Still referring to FIG. 15 , as the stomach lumen is pressurized and thesecond medical device is urged against the first medical device, thetissue surrounding the first medical device 100 will press against eachsegment 104 a. The backpressure at each segment 104 a will vary basedupon the magnitude of the tissue tension as a function of the inflationpressure and as the second medical device is clamped. Each segment 104 amay have a predetermined backpressure value that indicates that thedesired tissue tension has been achieved for the respective segment 104a and related area of the sleeve. Once the predetermined pressure isreached, the second medical device 300 is closed for that segment 104 aof the desired sleeve. Where the shaping portion 104 includes more thanone segment 104 a, the stomach continues to be tensioned with positivepressure in the lumen until the predetermined pressure of the nextshaping portion segment 104 a is reached (again indicating the desiredtissue tension has been achieved in that segment 104 a of the sleeve).When that desired tension is reached, that portion of the second medicaldevice 300 is closed. This is continued until the entire second medicaldevice 300 is closed, thus ensuring the entire sleeve was formed to havethe desired tension lines. Having multiple segments 104 a allows fordifferent shapes for different portions of stomach (e.g., body 26, IA20, antrum 22). In an embodiment where the pressure data is beingdisplayed to the surgeon, the pressure of the shaping portion 104 orindividual segments 104 a may be ‘zeroed’ after inflating the shapingportion and before inflating the stomach lumen. This may all the surgeonor other user to easily visualize small changes in backpressure, whichmay be small relative to the overall pressure keeping the ballooninflated.

Referring now to FIGS. 16A-16C, in an example embodiment, the shapingportion 104 may be segmented along the length thereof. Each segment 104a may be coupled to a pump and one or more sensors, as discussed above.Based on the magnitude of the backpressure each segment 104 a isexperiencing, the system and/or the surgeon may be able to determine theposition of the surrounding tissue before clamping the second medicaldevice. For example, the segments 104 a adjacent the lesser curvature 16experiencing a relatively high backpressure may indicate that the lessercurvature 16 of the stomach is in the desired position relative to thefirst medical device 100 (FIG. 16B). Additionally, all of the segments104 a experiencing a relatively high backpressure may be an indicationthat the tissue surrounding the first medical device 100 is in thedesired position and the second medical device 300 may be clamped (FIG.16C).

In various embodiments, the system may use dynamic feedback to reach thedesired pressure in both the shaping portion and the stomach lumen. Forexample, the system may adjust the inflation (e.g., add more pressure oruse suction to reduce pressure) of the stomach lumen and/or the shapingportion based on feedback from the first medical device. The pressuremay be adjusted manually or automatically based on the feedback. Thefirst medical device could include one or more segments coupled to oneor more sensors, such as with the configurations in FIGS. 15-16C. Themeasured backpressure at the one or more segments may be used indetermining whether to increase, maintain, or reduce pressure in thestomach lumen. In some embodiments, inflation and suction may bealternated to position portions of the stomach tissue relative to thesecond medical device as desired. The backpressure on the shapingportion may slightly increase after the second medical device isclamped.

In various embodiments, feedback other than backpressure on the firstmedical device may be used to determine when to clamp the second medicaldevice. For example, the first medical device may be configured todetermine whether the tissue surrounding the first medical device isproperly tensioned. The first medical device may be configured tomeasure suction in zones along the length of the first medical device.The shaping portion, for example, can include more than one sets ofsuction apertures (or other openings as discussed above). The suctionsapertures may be arranged in zones or separate segments. For example, asshown in FIGS. 17A and 17B, four zones of suction apertures 187 arearranged around a diameter of the tube portion 102 of the first medicaldevice 100. The suction apertures 187 may extend along the first medicaldevice 100 for about the length of the stomach (e.g., about 21 cm). Eachof the suction apertures 187 in the same zone are collectively coupledto a pump (e.g., a single pump or individual pumps) and a sensor. Forexample, a lumen 189 may couple each suction aperture 187 in arespective zone with the pump. Although not shown, the shaping portion104 may define channels for each of the suction apertures 187 such thatthe shaping portion 104 does not interfere with suction from the tubeportion 102. As the stomach is inflated and the second medical device300 is being urged against the first medical device 100, suction may beapplied to each zone. An example negative pressure may be in a range ofabout 20 mmHg to about 200 mmHg, in a range of about 115 mmHg to about135 mmHg, or about 125 mmHg. The system may be configured to determinewhen the suction apertures 187 in each zone become occluded (e.g., byadjacent tissue). The suction may be discontinued in a zone where thesuction apertures 187 have become occluded. Based on the number of zonesthat are occluded or which specific zones are occluded, the systemand/or the surgeon may be able to determine the position of thesurrounding tissue before clamping the second medical device. Forexample, two of four zones being occluded may indicate that the lessercurvature 16 of the stomach is grounded to the first medical device.Additionally, all of the zones being occluded may be an indication thatthe tissue surrounding the first medical device 100 is in the desiredposition and the second medical device 300 may be clamped.

It will be recognized that the number and configuration of suction zonesmay vary. For example, with reference to FIGS. 18A-18D, the firstmedical device may include 8 suction zones. The shaping portion 104 ofthe first medical device 100 may include a separate lumen 190 for eachzone. The lumens 190 may each extend from a closed proximal end 192 toan open distal end 194 and be in communication with a plurality ofsuction apertures 196. The tube portion 102 of the first medical device100 may include tube openings 198, each of which correspond to aseparate lumen 190. The tube openings 198 may be collectively coupled toa pump. In an embodiment, the tube openings 198 are positioned on asidewall 200 of the tube portion 102 adjacent the distal end 108. Eachtube opening 198 and corresponding lumen 190 are in fluid communicationwith each other. For example, the shaping portion 104 may include amanifold cap 202 that couples each tube opening 198 to the correspondinglumen 190. The manifold cap 202 may be segmented, and the number ofsegments may correspond to the number of suction zones. The manifold cap202 may include an inner wall 204 defining a channel 206 sized toreceive the distal end 108 of the tube portion 102. The inner wall 204also defines apertures 207 configured to align with the tube openings198 when the tube portion 102 extends into the channel 206. Extendingfrom the inner wall 204 are dividers 208 that define a series ofchambers 210, each chamber 210 corresponding to one of the apertures207. When assembled, each chamber 210 fluidly couples each aperture 207with a corresponding open distal end 194 of a lumen 190. The dividers208 prevent or substantially prevent airflow between each chamber 210.With such a configuration, one source of suction is coupled to multipleindependent zones. The manifold cap 202 may also include an outlet 212at its distal end. The outlet 212 may allow the lumen 120 in the tubeportion 102 to be in communication with the stomach lumen (e.g., tocontrol the pressure in the stomach lumen). As described above, thezones of suction may be used by the surgeon or system to determine theposition of tissue surrounding the first medical device 100 and/or whento clamp the second medical device 300.

With reference to FIGS. 19A and 19B, in various embodiments, the firstmedical device 100 may include suction lumens 214 positioned on anexterior of the shaping portion 104. Each suction lumen 214 may includeone or more suction apertures (not shown for clarity purposes). Thesuction lumens 214 may each be coupled to a pump. The system may beconfigured to measure the suction applied through each lumen 214. Forexample, each lumen 214 may be coupled to a sensor. In an embodiment,the suction lumens 214 are positioned longitudinally around a diameterof the shaping portion 104. The suction lumens 214 may be flexible toallow for expansion when the shaping portion 104 is inflated orexpanded. In various embodiments, the suction lumens 214 may be coupledto the shaping portion 104 or held in position on the shaping portion104 by, for example, an outer elastic sheath 216. The elastic sheath 216is porous or otherwise perforated to allow suction from the suctionlumens 214 through the elastic sheath 216. As discussed above, thesystem may be configured to determine when the suction apertures in eachlumen 214 become occluded (e.g., by adjacent tissue), which can be usedto inform the system or the surgeon about the current state of theprocedure or whether it is time to clamp the second medical device.

While several devices and components thereof have been discussed indetail above, it should be understood that the components, features,configurations, and methods of using the devices discussed are notlimited to the contexts provided above. In particular, components,features, configurations, and methods of use described in the context ofone of the devices may be incorporated into any of the other devices.Furthermore, not limited to the further description provided below,additional and alternative suitable components, features,configurations, and methods of using the devices, as well as variousways in which the teachings herein may be combined and interchanged,will be apparent to those of ordinary skill in the art in view of theteachings herein.

Versions of the devices described above may be actuated mechanically orelectromechanically (e.g., using one or more electrical motors,solenoids, etc.). However, other actuation modes may be suitable as wellincluding but not limited to pneumatic and/or hydraulic actuation, etc.Various suitable ways in which such alternative forms of actuation maybe provided in a device as described above will be apparent to those ofordinary skill in the art in view of the teachings herein.

Versions of the devices described above may have various types ofconstruction. By way of example only, any of the devices describedherein, or components thereof, may be constructed from a variety ofmetal and/or plastic materials.

Having shown and described various versions in the present disclosure,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, theexamples, versions, geometrics, materials, dimensions, ratios, steps,and the like discussed above are illustrative and are not required.Accordingly, the scope of the present invention should be considered interms of the following claims and is understood not to be limited to thedetails of structure and operation shown and described in thespecification and drawings.

What is claimed is:
 1. An apparatus for performing a sleeve gastrectomy,the apparatus comprising: (a) a bougie for insertion into an interior ofa stomach, the bougie having a proximal bougie end and a distal bougieend; (b) an inflation lumen having a proximal lumen end and a distallumen end, the inflation lumen extending from the proximal bougie endthrough the distal bougie end; (c) a fluid delivery system coupled withthe proximal lumen end, the fluid delivery system having a first mode inwhich the fluid delivery system delivers positive pressure in apredetermined positive pressure range into the stomach prior to thestomach being resected, the predetermined positive pressure range beingbased on a size or a shape of the stomach prior to the stomach beingresected, and a second mode after the stomach has been resected; and (d)a monitor coupled with the proximal lumen end operably configured forthe monitoring of pressure or volume within the stomach, and to providean indication when the predetermined positive pressure range is reached,wherein the bougie is operably configured to define a resection line forthe sleeve gastrectomy when the predetermined positive pressure range isachieved within the stomach, wherein the resection line is defined atleast partially by the position of the bougie relative to a secondmedical device clamped externally on the stomach laterally adjacent tothe bougie at a first amount of compression or a second amount ofcompression, wherein the second amount of compression is both greaterthan the first amount of compression and operably configured toimmovably retain the stomach while at the predetermined positivepressure range, wherein the bougie includes at least one sensor coupledwith the distal bougie end for monitoring a pressure within the stomach,wherein the monitor is configured to provide the indication that thepredetermined positive pressure range is reached to the second medicaldevice based on output of the at least one sensor, and wherein theindication is configured to cause the second medical device to clamp thestomach at the second amount of compression, and wherein the apparatusis configured to simultaneously deliver the positive pressure andprovide suction.
 2. The apparatus of claim 1, wherein the bougieincludes at least one balloon portion positioned at the distal bougieend.
 3. The apparatus of claim 1, wherein the inflation lumen can beused for both inflation and suction.
 4. The apparatus of claim 1,wherein the fluid delivery system is a hand pump or a foot pump.
 5. Theapparatus of claim 1, wherein the monitor comprises a visual indicatoror an audible indicator, and wherein the monitor is configured toprovide the indication that the predetermined positive pressure range isreached to a user via the visual indicator or the audible indicator. 6.The apparatus of claim 1, wherein the monitor comprises a control systemfor metering a fluid delivered through the inflation lumen.
 7. Theapparatus of claim 1, wherein the bougie includes a shaping portionpositioned at the distal bougie end.
 8. The apparatus of claim 7,wherein the shaping portion is a balloon.
 9. The apparatus of claim 7,wherein the bougie includes an articulating tip, wherein the suction isprovided at the articulating tip.
 10. The apparatus of claim 1, furthercomprising an overtube positioned on the distal bougie end.
 11. Theapparatus of claim 1, wherein the bougie includes a multi-lumencatheter.
 12. The apparatus of claim 1, wherein the predeterminedpositive pressure range is from 15 mmHG to 20 mmHG.
 13. An apparatus forperforming a sleeve gastrectomy, the apparatus comprising: (a) a bougiefor insertion into an interior of a stomach, the bougie having aproximal bougie end and a distal bougie end; (b) an inflation lumenhaving a proximal lumen end and a distal lumen end, the inflation lumenextending from the proximal bougie end through the distal bougie end;(c) a fluid delivery system coupled with the proximal lumen end, thefluid delivery system having a first mode in which the fluid deliverysystem delivers positive pressure in a predetermined positive pressurerange of positive pressure into the stomach prior to the stomach beingresected, the predetermined positive pressure range being based on asize or a shape of the stomach prior to the stomach being resected, anda second mode after the stomach has been resected; and (d) a controlsystem coupled with the proximal lumen end for the metering andmonitoring of pressure or volume within the stomach, wherein the controlsystem is configured to provide an indication when the predeterminedpositive pressure range is reached, wherein the bougie is operablyconfigured to cooperate with a stapler or clamp that is clampedexternally on the stomach laterally adjacent to the bougie at a firstamount of compression or a second amount of compression to define aresection line for the sleeve gastrectomy when the predeterminedpositive pressure range is achieved within the stomach, wherein thesecond amount of compression is both greater than the first amount ofcompression and operably configured to immovably retain the stomachwhile at the predetermined positive pressure range, wherein the bougieincludes at least one sensor coupled with the distal bougie end formonitoring a pressure within the stomach, wherein the control system isconfigured to provide the indication that the predetermined positivepressure range is reached to the stapler or clamp based on output of theat least one sensor, and wherein the indication is configured to causethe stapler or clamp to clamp the stomach at the second amount ofcompression, and wherein the apparatus is operably configured tosimultaneously deliver the positive pressure and provide suction. 14.The apparatus of claim 13, wherein the bougie includes at least oneballoon portion positioned at the distal bougie end.
 15. The apparatusof claim 13, wherein the inflation lumen can be used for both inflationand suction.
 16. The apparatus of claim 13, wherein the fluid deliverysystem is a hand pump or a foot pump.
 17. The apparatus of claim 13,wherein the control system comprises a visual indicator or an audibleindicator, and wherein the control system is configured to provide theindication that the predetermined positive pressure range is reached toa user via the visual indicator or the audible indicator.
 18. Theapparatus of claim 13, wherein the control system comprises a controlsystem for metering and monitoring a fluid delivered through theinflation lumen.
 19. The apparatus of claim 13, wherein the bougieincludes a shaping portion positioned at the distal bougie end.
 20. Theapparatus of claim 19, wherein the shaping portion is a balloon.
 21. Theapparatus of claim 19, wherein the bougie includes an articulating tip,wherein the suction is provided at the articulating tip.
 22. Theapparatus of claim 13, further comprising an overtube positioned on thedistal bougie end.
 23. The apparatus of claim 13, wherein the bougieincludes a multi-lumen catheter.
 24. The apparatus of claim 13, whereinthe predetermined positive pressure range is from 15 mmHG to 20 mmHG.25. A system for performing a sleeve gastrectomy, the system comprising:(a) a first medical device, the first medical device including; (i) abougie for insertion into an interior of a stomach, the bougie having aproximal bougie end and a distal bougie end, (ii) an inflation lumenhaving a proximal lumen end and a distal lumen end, the inflation lumenextending from the proximal bougie end through the distal bougie end,(iii) a pump coupled with the proximal lumen end, the pump having afirst mode in which the pump delivers positive pressure in apredetermined positive pressure range into the stomach prior to thestomach being resected, the predetermined positive pressure range beingbased on a size or a shape of the stomach prior to the stomach beingresected, and a second mode after the stomach has been resected, (iv) amonitor coupled with the proximal lumen end for the monitoring ofpressure or volume of the stomach, and configured to provide anindication when the predetermined positive pressure range is reached,and (v) a shaping portion, the shaping portion being positioned at thedistal bougie end, wherein the shaping portion is operably configured toposition a portion of the stomach, wherein the first medical device isoperably configured to simultaneously deliver the positive pressure andprovide suction, and (b) a second medical device, the second medicaldevice being a stapler or clamp positioned externally on the stomachlaterally adjacent to the first medical device; wherein the firstmedical device and the second medical device are operably configured todefine a resection line for the sleeve gastrectomy when thepredetermined positive pressure range is achieved within the stomach,wherein the resection line is defined at least partially by the positionof the first medical device relative to the second medical device;wherein the first medical device includes at least one sensor coupledwith the distal bougie end for monitoring a pressure or volume withinthe stomach, wherein the monitor is configured to provide the indicationthat the predetermined positive pressure range is reached to the secondmedical device based on output of the at least one sensor, and whereinthe indication is configured to cause the second medical device to clampthe stomach at the second amount of compression; and wherein the secondamount of compression is both greater than the first amount ofcompression and operably configured to immovably retain the stomachwhile at the predetermined positive pressure range.
 26. The system ofclaim 25, wherein the bougie includes at least one balloon portionpositioned at the distal bougie end operably configured to shape asleeve resulting from the sleeve gastrectomy.
 27. The system of claim25, wherein the monitor comprises a visual indicator or an audibleindicator, and wherein the monitor is configured to provide theindication that the predetermined positive pressure range is reached toa user via the visual indicator or the audible indicator.